Isolated Anti-HBc Serological Profile in HIV Infected Patients: Immunological, Virological Characteristics and Response to Hepatitis B Vaccination

HIV Infection Clinical Trial

— ANRSHBEP03  

Official title:

Study of Immunological, Virological, Serological Characteristics of HIV+ Patients Harboring Isolated Anti-HBc Profile and Response to Hepatitis B Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323308
• Other study ID #: ANRS HB EP 03 CISOVAC
• Secondary ID: 2010-A00511-38
• Status: Completed
• Phase: N/A
• First received: July 11, 2014
• Last updated: December 22, 2014
• Start date: December 2010
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

The aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• HIV+ adults patients

• negative HBsAg

• negative a-HBs Ab

• positive HBc Ab

• without HBV - vaccination

• CD4 cell above 200 /mm3

• HIV viral load below 50 copies/mL

Exclusion Criteria:

• positive HBs antigenemia in the past

• transaminitis above fivefold upper normal limit

• PT<50% or Platelet <50 000/mm3

• ongoing opportunistic infection

• ongoing or recent systemic corticoid or immunomodulatory therapy, splenectomy, pregnancy, contra-indication to intramuscular injection, familial history of neurological disease.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• HIV Infection

Intervention

Other:
• blood sampling

Locations

Country	Name	City	State
France	Chu Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of immunological, virological and serological characteristics associated to "anti-HBc isolated" profile		at Day 0, inclusion visite	No
Primary	Average titers of anti-HBs Ab		at 4 weeks, 28 weeks and 18 months after the first vaccination HBV	No
Primary	Analysis of B-cell phenotype and maturation		at baseline and at week 28	No
Secondary	Number of patients with HBsAb titers as protective titer>10 IU/L		at 4 weeks,28 weeks and 18 month after the first dose HBV vaccin	No
Secondary	Detection of IgG+ memory B cells specific for HBcAg or HBs Ag		at baseline and 28 weeks after the first dose HBV vaccin	No
Secondary	- Detection of HBV preS2 and S-specific T cells		at day 0 and week 28	No